Director of Quality Operations

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Fort Lauderdale, FL, US

Summary

The Director of Quality Systems is responsible for the leadership, development, implementation, and ongoing effectiveness of the Company’s Quality Management System (QMS), supporting dietary supplement manufacturing, laboratory operations, and third-party/contract manufacturing activities. This position provides strategic and operational Quality leadership to ensure products are manufactured, tested, packaged, labeled, held, and distributed in accordance with established specifications, company procedures, and applicable regulatory requirements, including 21 CFR Part 111 and 117 Current Good Manufacturing Practice (cGMP) for Dietary Supplements.

Key Responsibilities

• Lead, develop, implement, and maintain the Company’s Quality Management System (QMS) in accordance with 21 CFR Part 111 and 117, applicable cGMP requirements, established specifications, and company procedures.
• Provide Quality leadership and oversight of manufacturing operations, ensuring appropriate controls are maintained from raw material receipt through manufacturing, packaging, testing, product release, storage, and distribution.
• Provide leadership and oversight of Quality Control laboratory operations, including analytical and microbiological testing, laboratory investigations, method suitability, equipment qualification/calibration, data integrity, and testing timelines.
• Manage Quality oversight of third-party/contract manufacturers, contract laboratories, and critical suppliers, including qualification, audits, Quality Agreements, performance monitoring, investigations, CAPAs, and change notifications.
• Ensure appropriate specifications, testing requirements, and acceptance criteria are established and maintained for components, raw materials, in-process materials, bulk products, packaging materials, labels, and finished products.
• Oversee product review, approval/rejection, and release activities, ensuring required manufacturing documentation, laboratory testing, investigations, and Quality requirements are satisfactorily completed prior to disposition.
• Lead and oversee deviations, nonconformances, OOS/OOT investigations, CAPAs, change controls, complaints, and other quality events, ensuring appropriate root-cause analysis, risk assessment, corrective actions, and timely closure.
• Establish, monitor, and report Quality KPIs, metrics, and trends to identify compliance risks, recurring issues, operational performance concerns, and opportunities for continuous improvement.
• Oversee key Quality systems, including document control, SOP management, cGMP training, supplier qualification, returned goods, reserve samples, complaints, and record retention.
• Ensure appropriate Quality oversight of Master Manufacturing Records (MMRs), Batch Production Records (BPRs), specifications, laboratory records, and other documentation required to demonstrate compliance with 21 CFR Part 111.
• Ensure Quality Control responsibilities for the approval or rejection of components, packaging, labels, in-process materials, and finished products are appropriately executed and documented.
• Provide Quality oversight for equipment qualification, calibration, validation, cleaning and sanitation programs, environmental monitoring, and other manufacturing or laboratory systems impacting product quality.
• Lead Quality activities associated with FDA inspections, regulatory inspections, customer audits, supplier/contract manufacturer audits, and third-party certification audits, including preparation, responses, CAPAs, and follow-up activities.
• Maintain…